IA #89-01 - Revised 3/19/97, "Electrical Muscle Stimulators and Iontophoresis
Devices", Attachment I, 10/26/06, II, 7/18/06
*Note: This import alert is reissued to update the format,
product code, and Center contact person. Changes and
updates are identified with an asterisk (*).*
TYPE OF ALERT: Intensified Coverage
*(Note: This import alert contains guidance to FDA field
personnel only. It does not establish any requirements, or
create any rights or obligations on FDA or on regulated
entities.)*
PRODUCT: Electrical Muscle Stimulators and Iontophoresis Devices
PRODUCT CODES: *89IPF (Muscle Stimulators)
89KTB (Iontophoresis)*
PROBLEM: Labeling - These electrical devices are prescription devices
and are misbranded when labeled for lay use. In addition,
the muscle stimulators are misbranded when inappropriate
claims, such as weight reduction, are made.
PAC: 82007
COUNTRY: All
MANUFACTURER/
SHIPPER: Various (see attachment)
CHARGE: If appropriate, charge:
Devices lacking prescription legend or otherwise not in
compliance with 21 CFR 801.109:
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be a prescription
device labeled for lay use, and thus lacks adequate
directions for its use [Misbranded, 502(f)(1)]."
Devices with inappropriate claims:
"The article is subject to refusal of admission pursuant to
section 801(a)(3) in that it appears to lack adequate
directions for its intended use [Misbranded, 502(f)(1)]."
Devices with labeling claims that are false and misleading:
"The article is subject to refusal of admission pursuant to
section 801(a)(3) in that its labeling appears to be false
or misleading [Misbranded, 502(a)]."
Devices marketed without premarket notification:
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears that a premarket
notification was not submitted pursuant to section 510(k)
[Misbranded, 502(o)]."
Charges may be combined as appropriate.
Note: Depending on the actual electromechanical
configuration of the device it may also be misbranded within
the meaning of Section 502(f)(2).
RECOMMENDING
OFFICE: CDRH and SAN-DO
REASON FOR
ALERT: The use of these electrical devices in health clubs, beauty
salons and figure salons has been increasing for several
years. While there are legitimate uses for both muscle
stimulators and iontophoresis devices, they are prescription
devices and are misbranded when labeled for lay use. In
addition, muscle stimulators are misbranded when any of the
following claims are made: girth reduction, loss of inches,
weight reduction, cellulite removal, bust development, body
shaping and contouring, and spot reducing.
A large number of these products are imported with the list
increasing (see attachments I and II). The following
information is provided to aid the districts in identifying
and detaining misbranded muscle stimulators and
iontophoresis devices.
Muscle Stimulators:
Electrical muscle stimulators are prescription devices used
to repeatedly contract muscles by passing electrical
currents through electrodes in contact with the body. One
or more pairs of electrodes, along with creams or gels, may
accompany the device, which may be powered by battery or
line voltage. There are currently no acceptable uses for
these devices when labeled for over-the-counter use. When
labeled for Rx use by a licensed practitioner, the following
uses are generally recognized as acceptable:
1. Relaxation of muscle spasm.
2. Prevention or retardation of disuse atrophy.
3. Muscle reeducation.
4. Increasing local blood circulation.
5. Immediate postsurgical stimulation of calf muscles to
prevent venous thrombosis.
6. Maintaining or increasing range of motion. The
labeling must contain the prescription legend and
comply with all the conditions of 21 CFR 801.109.
Muscle stimulators are misbranded when any of the following
claims are made: girth reduction, loss of inches, weight
reduction, cellulite removal, bust development, body shaping
and contouring, and spot reducing.
Iontophoresis Devices
An iontophoresis device is a prescription device used to
introduce ions of soluble salts (i.e., medications) by use
of direct current into the tissues of the body for
therapeutic or diagnostic purposes.
There are currently no acceptable uses for iontophoresis
devices when they are labeled for over-the-counter use.
When labeled for Rx use by a licensed practitioner, the only
approved use is the diagnosis of cystic fibrosis explained
in the final classification 21 CFR Part 890.5525, * or for
use with a drug, if labeling includes adequate directions
for use of the device with that drug.*
All other uses would result in the device being considered
Class III, requiring premarket approval.
The labeling for this device must contain the prescription
legend and comply with all the required information of 21
CFR 801.109.
The names of these devices, the names of the companies and
the labeling claims may change in the future. Some devices
are being promoted for both muscle stimulation and
iontophoresis. There is no objection to combined labeling or
use as long as the labeling requirements for both uses are
met and FDA has determined it to be substantially equivalent
to preamendment electrical muscle stimulators and
iontophoresis devices.
GUIDANCE: *Consult the Center for Devices and Radiological Health
(HFZ-343), Edgardo Santiago at (301) 594-4659* about
appropriate charges, adequate warnings, and whether
detention is warranted.
*For questions or issues concerning science, science policy,
sample collection, analysis, preparation, or analytical
methodology, contact the Division of Field Science at (301)
443-3320 or 3007.*
FOI: No purging required.
KEYWORDS: Electric Muscle Stim, Iontophoresis Device, Muscle
Stimulators, Slendertone.
REVISED BY: Alwin Collins, O & P SDWG, DIOP, (301) 443-6553.
DATE LOADED
INTO FIARS: MARCH 19, 1997
Import Alert #89-01 10/26/06
Attachment I
KNOWN MANUFACTURERS OF ELECTRICAL MUSCLE STIMULATORS
Manufacturer Importer Name of Device
Anti-Aging International Unknown Electrical Muscle
Inc. Stimulator
76 Hazelton Avenue 6/30/95
Toronto, Ontario
Canada M5R 2E2
MID #XOCANTAGI76TOR
Shipper:
Name Unknown
122 Davenport Road
Toronto, Ontario Canada
MID# CAUNK122TOR
Body Clock Health Care Ltd. Electronic Muscle Stimulator
108 George Lane 89I--PF
South Woodford 10/26/06
London, UK
FEI# 3003267895
Bretherton Therapy Products Lipodren
29 Orchard Road Muscle Stimulator
Beeston, Sandy, 84NFO, 89IPF
Bedfordshire SG19 1PJ 89NGX, 89LPQ
United Kingdom 7/20/05
FEI# 3003057408
Compex S.A. Compex-Sport Electrical Muscle
Chemin du Devent Stimulator/89IPF
CH-1024 Ecublens 5/23/01
Switzerland
FEI #3002806744
SHIPPER:
Chau Sport
5 Rue President Favre
Annecy, France
FEI #3003232528
Daito Electric Machine Industry Co. Ltd Stimulator, Muscle, Powered
9-11, Showa-Cho (body building belt)
Higashi-Osaka, Japan OSIM Pro-Therapist,
FEI #1000254767 Model OS-205
73BXM, 77ETN, 84NFO, 89IPF,
89MPH, 89NGX
8/29/02
Deutsche Nemectron Nemectron Belmont Electrodyn CII,
Germany New York, NY Dermaphoresis
Dezac, Ltd. Manufacturer Electronic Muscle
54 Bath Road Stimulator
Dr-Ho's Inc. Dr-Ho's Muscle Massage
P.O. Box 26543 Muscle Therapy Systems
Markville R.P.O. 89IPF
Markham, Ontario, Canada L3R0M4 4/17/00
FEI# 3002923277
Dr. Ho's Muscle Therapy
48 Norwich Drive
Markham, Ontario, Canada L3P 6R4
FEI# 3002267880
Dr. Ho's Inc.
176 Bullock Dr. #13
Markham, Ontario, Canada L3P 7N1
FEI# 3002923326
Cheltenham, Gloster 2/28/97
United Kingdom
FEI #1000599629
MID #GBDEZLTD54CHE
(Manufacturer) Stimulator, Muscle, Powered
Unknown (body building belt)
Ab-Sonic brand
(Shipper) (Importer) "the smart electronic massage
Comet (HK) Ltd. Fong Chan fitness belt"
Unit 1118-1119, Metro dba Tung Hing USA 73BXM, 77ETN, 84NFO, 89IPF,
Centre II Industries Co. 89MPH, 89NGX
21 Lam Hing St., Bay 501C Poplar Ave. 8/29/02
Kowloon, Hong Kong Millbrae, CA 94030
FEI #3003587846 FEI #3003570103
Edith Serei Co., Ltd. Edith Serei Co., Ltd. Electromass
Canada New Jersey
Formmagia S.R.L. AS 43 Suntronic Aesthetic
20089 Valleambrosia de Rozzano (MI) Treatment
Via Varalli 1, Capannone A/1, Italy 89IPF
FEI# 3005787843 84GXY
07/18/06
Formmagia S.R.L.
Via Giuseppe Frua 22
Milan, Italy
FEI# 3002928645
Generali Tecniche P-Ryton Corp. Dermaphoresis,
Elettroestetiche, Italy Long Island City, NY Vibroelectronic
Homesquare Int'l, Ltd. ABGYMNIC Electronic Gymnastic Device/
Rm. 3115,31/F Hong Kong 89--GZJ
Plaza 89--NHH
188 Connaught Road West 89--IPF
Hong Kong, 89--NFO
FEI #3003538851 89--NGX
89--ISA
89--LYG
6/27/02
International Esthetics Global Esthetics Multitone Muscle-
Corporation Seattle, WA toner
North Vancouver, B.C. Multitone Trans-
Canada dermal Facial Unit
Shipper:
Global Esthetics
Vancouver, B.C.,
Canada
Mayfair Medical Supplies The Scarf Co. Slim-up
Kowloon, Hong Kong Acupunture Equipment Beauty Pulse & Tens
Tucson, AZ 85705
Sa Mas S.r.l. N/A Attila Evoluzione
Via Tarlazzi 5 Electrical Stimulation
31014 Colle Umberto device
Umberto, Italy 84GZJ
FEI# 3003238077 4/11/01
Shenyang Xinzhen Medical Electronic BFGF-8 Computer Controlled
Instrument Company Weight Reducing Machine
No. 52, North Huanghe St Muscle Stimulator
Shengyang, 84NFO, 89IPF
China 89NGX, 89LPQ
FEI# 3004467572 7/20/05
Shenzhen Futian Light Industrial N/A Stimulator, Muscle, Powered
& Textile Products Import & (body building belt)
Export Co. 73BXM, 77ETN, 84NFO, 89IPF
6/F Futian Trade & Business Building 89MPH, 89NGX
Fuhua Road 51 6/20/02
Shenzhen, China
FEI #3003606121
Slendertone Ltd. Bloomex Int't. Slendertone
England New York, NY
Taiwan Creations Joe L. Co., Ltd. Home Slim
Taipei, Taiwan Healthtronic,
Muscle Stimulator
and Slimming System
2/1/94
Alpha-wave
Healthtronic,
Muscle Stimulator
and Slimming system
2/1/94
Ultra Scientific Instruments `Gloria Moore Inc. Ultratone EMS devices,
Ltd.(aka Ultratone) 82 Sidney Court including -
Kingnorth Technology Park San Rafael, CA Ultratone Facial
Wotton Rd., Ashford, 94903
Kent TN23 6LN FEI# 300205934 Stimulator
United Kingdom Ultratone Salon 10 Plus
FEI# 1000313394 Ultratone Pro 20
Ultratone Super Pro 20
Ultratone Futura Plus
89L- - PQ
5/9/01
Zot Nederland B.V. Amsterdam N/A Stimulator, Muscle, Powered
Lugano Branch Innuelle Brand Tex-El System
Corsa Elvezia 14 73BXM, 77ETN, 84NFO, 89IPF
CH-6900, Lugano, Switzerland 89MPH, 89NGX
FEI# 3003426581 6/20/02
Import Alert #89-01 7/18/06
Attachment II
KNOWN MANUFACTURERS OF IONTOPHORESIS DEVICES
Manufacturers Importer Name of Device
Generali Tecniche P-Ryton Corp. Lisa Derm,
Elettroestetiche, Italy Long Island City, NY Thermoslim,
Dermophoresis
Vibroelectronic
Deutsche Nemectron Nemectron Belmont Electrodyn CII,
Germany CII « New York, NY
Doctors Technology Co. Ltd. Up5 Skin care system- iontophoresis
614-3 Shinsa-dong, Kangnam-ku device
Seoul, Korea 89KTB
FEI# 3004429497 3/26/04
Shipper:
JMEC Co. Ltd.
Oshima Bldg. 3-31-3 Yushima
Bunkyo-ky, Tokyo, Japan
FEI# 3004429507
Edith Serei Co., Ltd. Edith Serei Co., Ltd. Galvanique,
Canada New Jersey Cathiolyse
Formmagia S.R.L. AS 43 Suntronic Aesthetic
20089 Valleambrosia de Rozzano (MI) Treatment
Via Varalli 1, Capannone A/1, Italy 89KTB
FEI# 3005787843 84GXY
07/18/06
Formmagia S.R.L.
Via Giuseppe Frua 22
Milan, Italy
FEI# 3002928645
Ionto-Comed Ionto-Comed U.S. Inc. Ionto-Lift No. 8223
Gmbh, West Germany St. Paul, MN
i2M Sarl 16 Bis N/A Idrostar,
Fosses Saint Julien Iontophoresis
BP200 14011 Device
Caen Cedax, France 89EGJ, 89KTB
FEI #3003614118
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